Robustness of the proposed HPLC method.

For routine measurement of Voriconazole (VZ) in a pure and gel formulation, a quick and accurate RP-HPLC technique with UV detection (254 nm) was developed. With a flow rate of 1.0 ml/min using a mobile phase that contained acetonitrile and water mixed 50:50, v/v. Internal standard approach was used for quantification. The method shows good linearity (correlation coefficient = 0.9999) with acceptable accuracy, precision and robustness. Three elements were taken into account to measure robustness. Flow rate, mobile phase composition, and pH all have an impact on the response, but only the flow rate which causes a reduction in the concentration of the drug—has a significant impact on the response. Analyst, equipment, and days were taken into consideration for a precision measurement. The analytical procedure had good precision, as seen by the %RSD which is found to be less than 2.0. The proposed method was straightforward, extremely sensitive, exact, and accurate, and it had a retention time of less than 4 minutes, indicating that it is appropriate for daily quality control.

为实现纯制剂与凝胶制剂中伏立康唑（Voriconazole, VZ）的常规含量测定，本研究建立了一种快速精准的反相高效液相色谱（RP-HPLC）紫外检测法，检测波长设为254 nm。该方法采用体积比50:50的乙腈-水溶液作为流动相，流速设定为1.0 ml/min，采用内标法进行定量分析。该方法线性关系良好，相关系数达0.9999，同时具备可接受的准确度、精密度与耐用性。为评价方法耐用性，本研究考察了三个影响因素：流速、流动相组成及pH值，三者均会对检测响应产生影响，但仅流速会因导致药物浓度降低而对响应产生显著影响。精密度考察纳入了分析人员、仪器与检测天数三个变量，结果显示方法精密度良好，测得的相对标准偏差（%RSD）均小于2.0。所建立的分析方法简便易行、灵敏度极高、专属性与准确度俱佳，且药物保留时间不足4分钟，适用于日常质量控制工作。